Clinical trial · Interventional
Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients
Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients - A Phase 1 Proton Dose Finding Trial -
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this phase 1 dose finding study is to to assess the clinical tolerability and safety of escalated dose proton therapy in glioblastoma patients treated with multimodality treatment, according to treatment volume. The main questions it aims to answer are: * what is the maximum tolerated proton dose in glioblastoma patients? * is the maximum tolerated proton dose in glioblastoma patients dependent on treatment volume? * what is the recommended phase 2 proton dose in glioblastoma patients? Patients will be asked to undergo radiotherapy to step-wise escalated doses using proton therapy as part of their multimodality treatment. Patients will be monitored closely for treatment effects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Escalated proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Escalated proton therapy
- interventionNames
- Radiation: Escalated proton therapy
Primary outcomes (2)
- measure
- Adverse Events
- timeFrame
- up til 2 years after the end of proton therapy
- description
- CTCAE version 5.0
- measure
- Dose Limiting Toxicities
- timeFrame
- up til 6 months after the start of proton therapy
- description
- CTCAE version 5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (main): * Newly diagnosed, contrast-enhancing GBM, IDHwt (WHO 2021 classification). * Maximal safe surgical resection is required; any extent of surgical resection is allowed (including biopsy-only). * Patient with target volume and location eligible for 60 Gy chemoradiotherapy. * Minimum distance between GTV and critical OAR (brainstem, chiasm, optic nerves and tracts in case of serviceable vision) of 5 mm on MRI-scan. * Age ≥ 18 years. * Karnofsky Performance Status grade of ≥ 70. * Adequate blood counts as assessed by treating physician. * Absence of any contraindication to undergo MRI and/or to receive Gadolinium contrast agent. * Before patient registration, written informed consent must be given according to Good Clinical Practice, and national/local regulations. Exclusion Criteria: * All eligibility criteria are formulated as inclusion criteria.
References
Publications (0)
Data not yet available